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Summary
This summary is machine-generated.

Quality by Design (QbD) and Design of Experiments (DoE) are key for pharmaceutical development. This review integrates DoE into the full lifecycle of oral tablet development, from formulation to validation, for systematic product realization.

Keywords:
critical process parameterscritical quality attributesdesign of experimentsprocess optimizationprocess validationquality by designtablet formulation

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Area of Science:

  • Pharmaceutical Science
  • Chemical Engineering
  • Drug Development

Background:

  • Quality by Design (QbD) and Design of Experiments (DoE) are crucial in pharmaceutical development.
  • Current approaches often separate formulation, process optimization, and validation.
  • A unified framework is needed for effective tablet development.

Purpose of the Study:

  • To provide a comprehensive review of integrating DoE into the full lifecycle of oral tablet development.
  • To demonstrate how formulation-level DoE can define, refine, and confirm design space.
  • To offer a practical framework for scientists and manufacturing teams.

Main Methods:

  • Narrative review of published case studies on oral tablet development.
  • Organization of case studies along a formulation-to-validation pathway.
  • Focus on translating Target Product Profile (TPP) into quality attributes and using DoE for formulation and process studies.

Main Results:

  • DoE outputs support probabilistic and mechanistic design space definition.
  • Integration of DoE with scale-up, technology transfer, and process validation (Stages 1-3).
  • Challenges identified in integrating DoE with Process Analytical Technology (PAT) and data-driven control.

Conclusions:

  • A practical framework for embedding DoE into QbD-based tablet development is presented.
  • Key gaps include limited use of probability-based design spaces and digitally enabled validation.
  • The review synthesizes DoE applications across the tablet development lifecycle.